GUEDEL AIRWAY

Airway, Oropharyngeal, Anesthesiology

MALLINCKRODT MEDICAL

The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Guedel Airway.

Pre-market Notification Details

Device IDK953400
510k NumberK953400
Device Name:GUEDEL AIRWAY
ClassificationAirway, Oropharyngeal, Anesthesiology
Applicant MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis,  MO  63134
ContactRobert A Virag
CorrespondentRobert A Virag
MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis,  MO  63134
Product CodeCAE  
CFR Regulation Number868.5110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-20
Decision Date1995-10-24

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